Wednesday, June 26, 2013

In Myriad the Supreme Court Has, Once Again, Increased the Uncertainty of U.S. Patent Law

On June 13 the U.S. Supreme Court issued a unanimous
decision in Association for Molecular
Pathology v. Myriad Genetics (Myriad)
which essentially upheld the patent eligibility of claims reciting cDNA
molecules encoding BRCA proteins, but struck down as patent ineligible claims
encompassing isolated fragments of BRCA-encoding genomic DNA. Unfortunately, as
a consequence of the manner in which the case was decided Myriad will in all likelihood only serve to increase the ambiguity and
uncertainty plaguing the U. S. patent system. Clearly, the mere isolation of a
naturally occurring biomolecule is no longer sufficient to confer patent
eligibility on the isolated product, regardless of how useful, nonobvious or
inventive the isolated product is relative to the prior art. What is less clear
is the patent eligibility status of a synthetic molecule that shares a common,
or highly similar, structure with a naturally occurring biomolecule.

I have written an article that addresses some of the ambiguities created by the Myriad decision, and the practical implications for patenting in
the life sciences arena.The article, which appears in Biotechnology Law Report, is
available here for the interested reader.

The court actually says that such synthetic DNA is "indistinguishable from natural DNA" and is therefore not patent eligible:

"[T]he lab technician unquestionably creates something new when cDNA is made. cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived. As a result, cDNA is not a 'product of nature' and is patent eligible under §101, except insofar as very short series of DNA may have no intervening introns to remove when creating cDNA. In that situation, a short strand of cDNA may be indistinguishable from natural DNA."

What does this suggest about the future of patents for non-gene natural products, e.g. those with pharmacologic activity isolated from plants? To quote Wikipedia "Prominent historical examples of such patents on isolated products of nature include adrenaline, insulin, vitamin B12..."

It seems clear that a product that is morphologically identical to a natural one, regardless of the process used to create it, is still a natural phenomenon. That is the reasoning seemingly employed, easily applied, and logical. No human intention or design went into the form of the product in either isolating or synthesizing it. It's not inventive. What's the problem?incidentally, this is my reasoning here: http://prezi.com/yzwld1xci2tc/?utm_campaign=share&utm_medium=copy

The intention behind the Supreme's verdict was not to leave a massive loophole in the patenting of PCR products from genomic DNA--I.E. they aren't patentable. Every lower court will acknowledge this intention and rule accordingly. If Myriad wants to waste more of its balance sheet cash in proving this, so be it. (MoveOn.bio)

It could be argued that the Myriad case was decided incorrectly. Please note the following. A gene is the combination of one or more regulatory sequences (promoters, enhancers, methyl groups) and an Open Reading Frame (ORF). It is therefore the case, that very few of the patents that putatively contain claims to genes actually have claims to genes. What company would want to make, use, and sell, a nucleic acid that is methylated? I would guess that almost no companies would want to patent a methylated nucleic acid. Instead, it is the case that nearly all of the so called "gene patents" have claims to ORFs. Also, it is the case that most of the discussions by the U.S. Supreme Court, and in the oral transcript of the U.S. Supreme Court, are arguably incorrect. The U.S. Supreme Courts decisions, thought-processes, comments during the oral hearing, are all arguably incorrect, because the participants failed to take into account that a "gene" is more than just a coding sequence. The U.S. Supreme Court failed to take into account that a gene includes one or more promoters, one or more enhancers, as well as the covalent methylation of the coding sequence, and covalent methylation of regulatory sequences. Please note that it would rarely be the case that any company would want to patent a coding sequence that is methylated. Because of the frequent, or perhaps even ubiquitous presence of covalently bound methyl groups on coding sequences, it can easily be argued that there do not exist any "gene patents" that claim a product of nature. It is possible, that there are a some "gene patents" where the claim requires the presence of methyl groups at naturally occurring positions, and requires the presence of naturally occurring promoters -- if so, then these patents would be claiming a product of nature and thus be not eligible for patenting. However, a claim to a nucleic acid that includes only coding sequences, and does not include any regulatory sequences (promoters) and does not include any methyl groups, should not be called a claim to a "gene."

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About Me

I am a law professor at the University of Missouri-Kansas City School of Law. My primary research interests lie at the intersection of biotechnology and intellectual property. This blog provides analysis and commentary on recent developments relevant to this area of the law.